Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 39,949 FDA device recalls.

DateProductReasonClassFirm
Sep 20, 2024 Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN01... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ00... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 remel BactiDrop Acridine Orange, REF 21502, 50 per package. A color change of the solution within the dropper can occur from orange-yellow to light yellow re... Class II Remel, Inc
Sep 20, 2024 Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgica... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgica... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgi... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: ... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgi... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surg... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: ... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN4... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVM... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and sur... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ00... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH00... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM04... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH01... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W... There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. Class I Maquet Cardiovascular, LLC
Sep 20, 2024 Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.